Health Fraud

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Cancer quackery from Germany to Australia

Quack, quack

Last week, I wrote about alternative medicine clinics in Germany that offer a combination of alternative cancer cures plus experimental therapeutics administered improperly outside the auspices of a clinical trial. In particular, I discussed two cases. The first was British actress Leah Bracknell, who is raising money to go to one of these alternative cancer clinics to treat her stage IV lung cancer. the second was a British woman named Pauline Gahan, who was diagnosed with metastatic stomach cancer and has thus far spent £300,000 for a combination of vitamin infusions, “detox,” and Keytruda (generic name: pembrolizumab). This is a drug belonging to a new class of promising anticancer therapies known as immune checkpoint inhibitors. It’s FDA-approved for some cancers, but hasn’t yet been shown to be effective against stomach cancer, although there is one phase I trial that is promising and thought to be sufficient evidence to justify phase II and III trials. None of this stopped the clinic to which both Bracknell and Gahan traveled, the Hallwang Private Oncology Clinic.

One thing I noticed about the Hallwang Private Oncology Clinic when I wrote about it is that nowhere did it list the doctors who own and operate it or who consult there. I did find one name, Dr. Jens Nolting, mentioned on patient discussion boards as working at Hallwang. The lack of mention of who runs the clinic and who practices there was an enormous red flag to me, I think for obvious reasons. Fortunately, a commenter with more knowledge than I and thus a better idea of what to Google for, jumped in to comment and helped out. So I thought I’d do a follow-up post and then segue to a report that aired on Australian TV on alternative medicine for cancer there to show the consequences of clinics like this, which are, unfortunately, a problem in many advanced countries. Thus, this post might be a bit “odds and ends”-ish, but it’s a topic that’s been of intense interest to me ever since I discovered the depths of alternative medicine applied to cancer, and I didn’t want to leave last week’s post, in essence, unfinished. Also, there is at least one interesting connection that I hadn’t realized as I wrote my post last week.
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Posted in: Cancer, Health Fraud, Naturopathy, Politics and Regulation, Science and Medicine

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German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it

Pauline Gahan in front of the Hallwang Private Oncology Clinic
A couple of months ago, I discussed patient deaths at an alternative medicine clinic in Europe, where a naturopath named Klaus Ross had been administering an experimental cancer drug (3-bromopyruvate, or 3-BP) to patients outside the auspices of a clinical trial. 3-BP is a drug that targets the Warburg effect, a characteristic of cancer cells first reported in the 1920s by Otto Warburg in which the cancer cell changes its metabolism to shut off oxidative phosphorylation (the part of glucose metabolism requiring oxygen that produces the most energy) to rely almost exclusively on glycolysis and anaerobic metabolism. From a cancer cell evolution standpoint, one can understand why cancer cells would behave this way, as this change allows them to survive in environments with much less oxygen than normal cells, but the side effect of the Warburg effect is that cancer cells consume a lot of glucose for their energy needs. Indeed, positron emission tomography (PET scanning) takes advantage of this characteristic of cancer cells to use glucose labeled with a positron-emitting isotope that accumulates in cells. The result is that cancer cells, which in general use a lot more glucose than normal cells, light up compared to the surrounding tissue, allowing the identification of areas suspicious for cancer. Targeting the Warburg effect is therefore a strategy to attack cancer cells preferentially.

Since I wrote about the tragic deaths of those cancer patients, I’ve been seeing stories about German alternative medicine cancer clinics popping up in my newsfeed over and over again. Intuitively, you’d think that a scientifically advanced economic powerhouse like Germany would have stricter regulations over the practice of medicine, but, the more I looked into these clinics, the more I realized that there are a lot of quack clinics in Germany every bit as quacky as any clinic in Tijuana, but with a twist. Like Mexican alternative medicine clinics, German clinics often charge enormous sums of money for treatments that range from the unproven to the dubious to pure quackery. However, in addition to the rank quackery, German cancer clinics include legitimate experimental drugs that are as yet unproven and might even only have cell culture or animal evidence supporting its potential efficacy. Indeed, 3-BP is just such an example. It is a legitimate candidate cancer drug that’s in the pipeline, having shown promise in cell culture and animal experiments, but that has no human data from systematic clinical trials yet, just a handful of anecdotes when it was tried in humans under desperate circumstances. Not surprisingly, Klaus Ross’ main clinic is in Germany, and, like so many other clinics there, he was administering an as-yet-unapproved drug to humans.

So, prodded by a couple of recent stories from the UK, I decided to take another look at these German cancer clinics.
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Posted in: Cancer, Clinical Trials, Health Fraud

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Is there a distinct standard of care for “integrative” physicians? The Woliner case

Board certification in family medicine and "integrative" medicine: different standards of care?

Board certification in family medicine and “integrative” medicine: different standards of care?

Florida Atlantic University student Stephanie Sofronsky was diagnosed with Hodgkin’s lymphoma in 2011, after review of her case by oncologists and pathologists at Moffitt Cancer Center in Tampa, the NIH/National Cancer Institute, and the Mayo Clinic in Jacksonville. By June of that year, a PET scan showed the cancer had progressed to her pelvic region. She decided to be treated locally by oncologist Neal Rothschild, MD, and met with him to discuss chemotherapy and ongoing management of her cancer. At this point, with Stage III Hodgkin’s lymphoma, she had an 80-85% chance of being in complete remission with appropriate treatment.

Unfortunately, at the same time, Sofronsky was also seeing Kenneth Woliner, MD, a family medicine practitioner. Despite the fact that world-renowned cancer specialists agreed that Sofronsky had Hodgkin’s lymphoma, and knowing that she was about to start chemotherapy, Dr. Woliner told Sofronsky that cancer was “low on his list” of possible medical concerns and that increased lymphoctyes shown in her tests were not indicative of cancer, insinuating that oncologists “often overreact” to the presence of lymphocytes and recommend chemotherapy before making an actual diagnosis. Dr. Woliner suggested instead that Sofronsky have her house tested for mold, which could be causing allergies, and therefore her symptoms. Convinced, Sofronsky pursued treatment for her allergies and cancelled her follow-up appointment with Dr. Rothschild.

Sofronsky complained repeatedly to Dr. Woliner of symptoms that were, as our good friend Orac points out, consistent with progressing lymphoma – back pain and pain and swelling in her lymph nodes, abdomen and legs, to the point of having to use a cane. Yet, Dr. Woliner, over the next couple of years, continued to attribute her symptoms mostly to her allergies and also thyroid issues and some other minor illnesses. On February 7, 2013, at her last visit to his office and in significant distress from pain and severe leg swelling, he ordered a 100 mg shot of iron, despite the fact that her blood tests showed she was not iron deficient. She rapidly decompensated and died in the hospital three days later of from complications of untreated Hodgkin’s lymphoma. (more…)

Posted in: Cancer, Ethics, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation

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Ultraviolet Blood Treatment Revisited

A man undergoing blood irradiation therapy.

A man undergoing blood irradiation therapy.

If there is one thing this election cycle has demonstrated it’s that, when ideology or emotions are involved, people can be entirely immune to facts. The narrative takes control, reinforced by motivated reasoning and confirmation bias.

Even worse, people tend to think they are actually informed, and are confident in their opinions, even when they are grossly misinformed. Regular contributors here frequently receive e-mails from people who truly believe they have it all figured out – modern medicine is a con and we are all shills, while alternative gurus speak the Truth. The confident reality distortion is amazing to behold.

A total lack of ethics and regulation

Let’s take one stunning example from the world of alternative medicine – ultraviolet blood treatment. Britt Hermes, who has contributed to SBM before, is an ex-naturopath who wrote recently about a medical device called the UVLrx. This is a device that is inserted into a vein like a catheter, and then emits UV light directly to the blood.

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Posted in: Health Fraud, Medical devices, Naturopathy

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FDA Looks At Dubious Stem Cell Clinics

Stamina-protest
Using stem cells to treat disease or improve recovery is an exciting area of research. The potential is undeniably great – these are cells that have the potential to differentiate into mature cells of a specific type. They can be used to replace damaged cells or improve the environment for cell function and recovery. Ideally stem cells can be developed from cells harvested from the patient themselves, so there is no issue of rejection.

Stem cell technology, however, is tricky and currently in its infancy. One challenging hurdle is to prevent transplanted stem cells from turning into tumors. We also need the cells to do what we want and to survive long enough to be useful. Research is progressing, but the potential for stem cells has not yet been realized.

Quackery in the gap

Into this gap between the hype and potential of stem cells and the current reality of the research there is a space where dubious stem cell clinics can thrive. I first wrote about dubious stem cell clinics debuting in China nine years ago. Despite various regulatory efforts these clinics continue to thrive.

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Posted in: Health Fraud, Politics and Regulation

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Patient Groups and Pseudoscience

Patients should get health information from doctors, not quacks.

Patients should get health information from doctors, not quacks.

The biggest challenge we face promoting high standards of science in medicine is not making our case to the community. Our case is rock solid, in my opinion, and backed by evidence and logic. There is no question, for example, that homeopathy is 100% bogus and should not be part of modern medicine.

Our challenge is that there are literally billions of dollars to be made selling fake medicine and dubious treatments. This means that unscientific practitioners have an immediate financial incentive to promote themselves and their treatments, and they will tirelessly do so, on any front they can find. Further, the stars of unscientific medicine have the resources to do so – to intimidate critics, cozy up to politicians, open centers in respected hospitals, and market their brand.

We simply don’t have the manpower to confront them on every front, and the mainstream scientific and medical communities are frankly just not paying enough attention. They are largely unaware that pseudoscience is infiltrating their profession right under their noses, or they have been lulled into thinking this is a small and benign phenomenon.

Patient groups

These many fronts in which science confronts pseudoscience include the media, hospitals, continuing education, journals, the marketplace, politics and regulation, and research funding.

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Posted in: Health Fraud, Naturopathy, Science and Medicine

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The stem cell hard sell

It's generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

It’s generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

Stem cells are magical. Stem cells are all-powerful. Stem cells cure everything. Stroke? No problem! Paralysis? Stem cells’ll fix it. Autism? Yes, even autism.

That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm.

I learned about the unrelentingly positive spin the media tend to place on stem cell treatments when I first started blogging about Gordie Howe’s stroke and Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies reached out to the Howe family to see if it could help him with its products. When Howe and McGuigan discovered that Howe was not eligible for any of their US clinical trials, they facilitated Howe’s receiving an unproven stem cell therapy through one of its partners in Mexico, Novastem, which uses Stemedica stem cell products to treat patients in its clinic, Clínica Santa Clarita. In the ultimate bit of privilege for a sports hero (or, as I saw it at the time and as it ultimately turned out, an excellent investment for marketing and advertising of Stemedica products) Gordie Howe even received the treatment for free, even though Clínica Santa Clarita charges everyone else around $30,000. Let’s just say that I didn’t find the explanations for waiving this rather massive fee in Gordie Howe’s case to be persuasive, and I was rather disturbed at the entitlement expressed by Howe’s son over it, who didn’t see the ethical problem at all. Nor did I find the excuses given by Stemedica and Novastem for why their clinical trial protocol in Mexico was so substandard.

It turns out that this new, poorly regulated industry operates a lot like the many quack cancer clinics that I’ve blogged about over the years and like a lot of other dubious businesses, such as multilevel marketing scams. This comes in the form of a recent paper in Stem Cells Translational Research by Paul Knoepfler, who describes attending a marketing seminar.
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Posted in: Health Fraud, Science and the Media

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3-Bromopyruvate: The latest cancer cure “they” don’t want you to know about

3-BP: A "safe" and "nontoxic" cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

3-BP: A “safe” and “nontoxic” cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

I’ve not infrequently written about various dubious and outright quack clinics in different parts of the word with—shall we say?—somewhat less rigorous laws and regulations than the US. Most commonly, given the proximity to the US, the clinics that have drawn my attention are located in Mexico, most commonly right across the border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That’s not to say that there aren’t a lot of quack clinics right here in the US (particularly for stem cell treatments), but, by and large, the clinics doing the truly dangerous stuff tend to be less common in the US.

There is, however, another country where alternative medicine clinics, particularly for cancer, are common and thriving, specifically Germany. I first learned of these clinics when the story of Farrah Fawcett’s battle with anal cancer hit the news nine years ago. Ultimately, she died of her disease at age 62, but before she did she sought treatment at a clinic in Germany, which administered alternative treatments as well as radioactive seed implants, the latter of which, despite sounding nice and “conventional,” were not standard-of-care for recurrent anal cancer. What this led me to learn is that German alternative cancer clinics tend to use both alternative medicine and experimental “conventional” medicine that has not yet been shown to be safe and effective in clinical trials.

I thought of Farrah Fawcett when news about a German cancer clinic hit the news again beginning more than a week ago, when two patients from the Netherlands and one from Belgium died shortly after having undergone treatment at the Biological Cancer Centre, run by alternative practitioner Klaus Ross in the town of Brüggen, Germany. Two others were hospitalized with life-threatening conditions. I didn’t blog about them at the time because the only reports I could find were those sent to me by readers, and they were in German or Dutch. They also didn’t have a lot of detail. Both reported that on July 25, a 43-year-old Dutch woman went to the Biological Cancer Center in Brüggen-Bracht for treatment of breast cancer and that she unexpectedly died on July 30 of unknown causes. The Dutch report stated that the death occurred under mysterious circumstances and that there were two other deaths, that of a Belgian woman the week before, and a Dutch man.

Elsewhere, Irish newspaper TheJournal.ie reports:

Dutch police, who are supporting the inquiry, appealed for information from other patients, as newspapers reported the clinic had been using an experimental transfusion.

Concern was first raised when a 43-year-old Dutch woman with breast cancer complained of headaches and became confused after being treated at the clinic on 25 July.

She later lost the ability to speak, and died on July 30 although the “cause of her death remains unclear,” the German prosecutors said in a statement earlier this week.

Later, it was learned that the identities of the suspected victims were Joke Van der Kolk, age 43; Leentje Callens, age 55; and Peter van Ouwendorp, age 55.

Unfortunately, the early reports were fairly basic, without much detail, and only a couple with any names. Fortunately, now there is an article in Science that reports more. It turns out that the suspected cause of death is an experimental cancer drug known as 3-bromopyruvate (3-BP) that has not yet been approved for use in humans. So what happened?
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Posted in: Basic Science, Cancer, Clinical Trials, Health Fraud

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What’s the harm? Stem cell tourism edition

What's the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There's the harm.

What’s the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There’s the harm.

It’s been over two weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena named after crappy pizza being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as I noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described in a three part series of posts (part one, part two, part three), it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters, for unproven stem cell therapies, which have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published last week in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells. (more…)

Posted in: Clinical Trials, Ethics, Health Fraud, Science and the Media

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How low antivaccine “warriors” will go: Of Facebook harassment reporting algorithm abuse and publicly attacking a 12 year old boy

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.
Marco Arturo

I was going to write about something else this week, but events over the last several days led me to change my mind. The first was the reaction of a pseudonymous antivaccine “warrior” going by the ‘nym Levi Quackenboss to a viral video posted by a 12-year-old boy named Marco Arturo. The second was my learning that other antivaccine “warriors” had resumed abusing the Facebook reporting algorithm to get pro-science advocates supporting vaccines banned from Facebook for periods up to 30 days and thereby silence them. I wrote about this latter tactic a couple of years ago, when the Australian antivaccine group the Australian Vaccination Network (AVN), or AVN (which was forced to rename itself the Australian Vaccination Skeptics Network in 2014), started abusing Facebook’s algorithm for reporting harassment and abuse in order to get members of the skeptic group Stop the Australian Vaccination Network (SAVN) temporary Facebook bans. It’s a tactic that has continued, with a fresh batch of temporary bans issued by Facebook in response to bogus complaints over the last few days.

I’ve frequently written about how often the preferred tactic of antivaccinationists and others pushing medical pseudoscience is not to answer criticism with evidence, science, and rational argument, but rather to respond with attacks and attempts to intimidate and silence. The reason, of course, is that they do not have any of that to support their beliefs. At some level, I suspect that many of them know it. Be that as it may, those of us who lament how few physicians and scientists, even those sympathetic to scientific skepticism, are willing to publicly speak out and call the quacks to task know that the consequences of doing so are often quite unpleasant: Online attacks, poisoning of one’s Google reputation, attempts to get one banned from Facebook, and, of course, the antivaccinationists’ favorite: Harassment through one’s job by complaining to one’s bosses. To illustrate these hazards, I’ll start with the story of Marco Arturo, before moving on to a more organized effort. (If you read my not-so-super-secret other blog, you’ll have heard of Marco’s story before, but I’ll summarize here as well.) Then I’ll update you on how Facebook continues to allow its reporting algorithms to be abused to silence pro-vaccine voices there. I’ll finish up with examples of what we at SBM have experienced and some thoughts on what can be done. (more…)

Posted in: Computers & Internet, Health Fraud, Vaccines

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